IPQ’s coverage of CMC and GMP developmentms in the Asia Pacific region continues in the February Monthly Update with an analysis of South Korea’s quest to harmonize and keep pace with the advancing international pharmaceutical quality regulatory paradigm.
Helping foster the paradigm advancement on the international level during February was a watershed announcement by FDA and EMA that they would be copiloting the joint review of QbD information in drug marketing and post-approval change applications. The breaking IPQ coverage encompasses the context of cooperation out of which the pilot is emerging and an explanation of its significance by US and European regulators involved in framing the initiative.
Another development driving forward the ICH Q8-10/QbD paradigm during February was FDA’s finalization of its process validation guidance, which pulls together the design, qualification and continued process verification stages into a comprehensive approach to assuring the control of a process through its lifecycle. The extensive vetting of the draft confirmed to the agency that only a relatively few clarifications were needed to bring it into final form. The IPQ story compares the two versions with the help of insights by PV working group co-chair Grace McNally on her group’s decision making.
Also in focus in the February issue is an analysis of how continuous manufacturing is bringing the new quality concepts onto the shop floor. Reflecting the growing regulator and industry interest in continuous manufacturing, the February issue includes the insights provided at recent ISPE and AAPS forums by two key CDER experts on these processes — reviewing official Christine Moore and compliance officer Francis Godwin. The GMP/quality system perspective on design and implementation provided by Godwin complements Moore’s exploration of the CMC/development implications of the new processing technologies.
FDA also focused during February on furthering the supply chain control effort. The agency held a workshop at its White Oak headquarters at which participants in the supply chain provided input on how to tackle the multi-layered problems around designing and implementing a viable track and trace system. The IPQ story focuses on the insights emerging from a State of California probe into the gaps in the heparin recalls and the implications on the need for a track and trace system.
On the CMC/review front, the analysis, significance and control of particulates in biotech products has been gaining attention from FDA regulators recently. Drawing on the insights provided by a key biotech CMC review official, Barry Cherney, at a January CMC strategy forum, the IPQ story addresses the particularly challenging issues and uncertainties around particles in the subvisible range.
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